Articles

Original Research

Published on 03 August 2020

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is...

adalimumab, anti-TNF therapy, biosimilars, clinical trials, injection-site pain, rheumatoid arthritis

DOI: 10.5639/gabij.2020.0903.019

10.355 views

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Published on 09 July 2020

2020/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2020, Issue 2 Commentary Importance of the determination of the higher order structure in the in-use stability studies of...

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Original Research

Published on 07 July 2020

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars...

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020

7.176 views

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Original Research

Published on 07 July 2020

Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Author byline as per print journal: Toshihiko Hibino1, MD; Tomohiko Yoshida2, MD, PhD; Akira Sagawa3, MD, PhD; Ikuko Masuda4, MD, PhD; Takaaki Fukuda5, MD Introduction/Study objective: Needle fear is common...

etanercept, injection pen, needle fear, rheumatoid arthritis, usability, YLB113

DOI: 10.5639/gabij.2020.0903.018

23.986 views

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Commentary

Published on 07 July 2020

Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their...

Author(s): Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP, regulatory harmonization

DOI: 10.5639/gabij.2020.0903.017

6.367 views

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Editor's Letter

Published on 02 July 2020

What to look forward to in GaBI Journal, 2020, Issue 2

This issue of the GaBI Journal is being published as the global coronavirus 2 (SARS-CoV-2) pandemic is expanding rapidly in many areas of the world including in the United States...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0902.008

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Regulatory

Published on 26 May 2020

Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines

Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European...

Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD

biosimilar, filgrastim, Neulasta®, pegfilgrastim, Pelmeg®, targeted development

DOI: 10.5639/gabij.2020.0903.021

18.326 views

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Review Article

Published on 26 May 2020

Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)

ASEAN, biopharmaceutical manufacturing, biopharmaceuticals, good manufacturing practice, harmonization, regulatory guidelines

DOI: 10.5639/gabij.2020.0902.010

19.983 views

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Special Report

Published on 29 April 2020

Clinical trials for trastuzumab biosimilars

Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried...

Author(s): GaBI Journal Editor

biosimilar, clinical trials, trastuzumab

DOI: 10.5639/gabij.2020.0902.014

4.968 views

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Meeting Report

Published on 25 March 2020

3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the...

Author(s): Jian Wang, MD, PhD, Professor Andrea Laslop, MD, Professor John-Joseph Borg, Robin Thorpe, PhD, FRCPath, Yolanda Elias Gramajo, MD

biologicals, biosimilars, Colombia, INVIMA

DOI: 10.5639/gabij.2020.0903.022

8.566 views

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Regulatory

Published on 25 March 2020

Regulatory pathway for approval of ‘biosimilars’ in Iran

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by...

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product

2.554 views

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